Abstract
Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. This chapter will provide an overview of the regulatory process and will discuss in more detail the quality and pre-clinical safety issues of plasmid DNA vaccines intended for human use. It is useful for research scientists to be aware of these processes as the development of a novel vaccine could be problematic due to the starting material often being developed in a research laboratory under ill-defined conditions.
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© 2000 Humana Press Inc., Totowa, NJ
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Robertson, J.S., Griffiths, E. (2000). Assuring the Quality, Safety, and Efficacy of DNA Vaccines. In: Lowrie, D.B., Whalen, R.G. (eds) DNA Vaccines. Methods in Molecular Medicine™, vol 29. Humana Press. https://doi.org/10.1385/1-59259-688-6:499
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DOI: https://doi.org/10.1385/1-59259-688-6:499
Publisher Name: Humana Press
Print ISBN: 978-0-89603-580-5
Online ISBN: 978-1-59259-688-1
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